MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER MEMBRANOUS VSD OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number 9-VSD-MEMB-014

Device Problem Biocompatibility (2886)

Patient Problems Syncope (1610); Complete Heart Block (2627)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, ten years after implant of an amplatzer membranous vsd occluder the patient was hospitalized with recurrent syncope, diagnosed with complete atrioventricular block and a permanent pacemaker was implanted.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported through a research article identifying 14mm amplatzer membranous vsd occluder (avsdo) that may be related to requirement for a permanent pacemaker implantation.The patient was successfully implanted with no arrhythmias, residual shunt, or aortic regurgitation observed following occluder deployment and release.The patient was discharged one week post-implant.The patient followed up clinically with 24-hour ecg and echocardiography at one, three, six, and 12 months during the first year and annually thereafter.Ten years after the implant, the patient was hospitalized due to recurrent syncope.A multitude of tests were performed.Based on the patient's history of amplatzer implant, device flattening on tte and exclusion of other possible etiologies resulting in complete atrioventricular block (cavb), it was ultimately considered that the cavb was likely to be associated with device closure using the avsdo.The patient was treated empirically with prednisone, but no improvement was observed.A permanent pacemaker was then implanted.Specific patient information is documented as unknown.Details are listed in the attached article, titled "very late-onset complete atrioventricular block following deployment of amplatzer membranous ventricular septal defect occluder.".

• Brand Name: AMPLATZER MEMBRANOUS VSD OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9612328
• MDR Text Key: 176271404
• Report Number: 2135147-2020-00008
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-VSD-MEMB-014
• Device Catalogue Number: 9-VSD-MEMB-014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR
• Patient Weight: 17